Colonoscopy (Procedure)
Conditions
Keywords
colonoscopy, sedation, patient controlled propofol sedation
Brief summary
The goal of this clinical trial is to learn if patient administered propofol sedation results in superior patient satisfaction compared to nurse administered propofol sedation in diagnostic colonoscopies. • Does self administration of the sedative propofol increase patient satisfaction? Researchers will compare patient administered propofol sedation (where the patient administers propofol by pushing a button) with nurse administered propofol sedation (where a nurse gives the patient bolus doses of propofol as deemed necessary) Participants will: * Be randomized to either sedation route. * Answer a preendoscopy questioneere and a postendoscopy questioneere 1 hour after the examination as well as one week after the examination.
Interventions
DRUGSelf administred propofol
Patients will self administer propofol by pushing a button. When pushed a dose of 5 mg propofol will be given intravenously. The button can be pushed a maximum of 8 times per minute.
DRUGNurse assisted propofol sedation
The endoscopy nurse will administer bolus dosus of propofol (10 mg iv) as needed during the examination
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Scheduled for elective diagnostic colonoscopy in propofol sedation * Able to understand the study information and provide inform consent * ASA I-II * Able to understand and use the patient-controlled sedation device * Able to complete study quistioneeres
Exclusion criteria
* ASA \>=III * Known hypersensitivity or contraindication to propofol or any excipient in the formulation. * Pregnancy or breastfeeding. * Inability to provide valid informed consent * Cognitive impairment, severe psychiatric illness, or other condition limiting reliable participation or questionnaire completion. * Inability to understand study procedures or insufficient language proficiency without available validated study support. * History of serious adverse reaction or complication related to sedation or anesthesia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | One hour after the examination and one week after the examination | Patient satisfaction measured using Patient satisfaction with sedation index (PSSI), a validated Likert-scale questionnaire with 13 questions. Each question with 5 ranks (1-5). Minimum score 13 , maximum score 65. Higher score indicates higher satisfaction with the sedation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total propofol dose (mg) | 0 hours after examination | Total given dose during the examination |
| Recovery time | 4 hours after the examination | Time to patient is ready for discharge. Patient will be assesed every 15 minutes until ready for discharge, maximum 4 hours |
| Procedure duration | 0 hours after examination | Time to completion of the procedure (min) |
| Adverse events | 30 days | Any adverse events related to sedation within 30 days |
Countries
Sweden
Contacts
CONTACTRichard E Marsk, Docent
PRINCIPAL_INVESTIGATORRichard E Marsk, Docent
Karolinska Institutet
Outcome results
None listed